Inhalator

ABSTRACT

654,872. Respiratory appliances. ABBOTT LABORATORIES. Aug. 20, 1948, No. 13228/50. Convention dates, Sept. 4, 1947 and April 30, 1948. Divided out of 654,860. [Class 81 (ii)] A container for dispensing finely divided material has a foraminated end and an external flange with radially extending lugs, remote from the foraminated end, for supporting it in a holder with the foraminated end in the path of a stream of air flowing through the said holder. The invention is described in relation to a medical device for the inhalation of powder of the type described in Specification 654,860 in which a ball 42 is raised by the suction of the patient when he inhales through a mouthpiece 48. At the top of its movement the ball 42 strikes against a cylindrical container 12 which is loosely supported in the body by its flanged end 30, so that medicated powder 14 is sprinkled through a gauze screen 16 into the air stream. The container is provided with a handle 20 and its rim has diametrically placed projections forming a bayonet catch which prevents it inadvertently falling from the body.

MIY 17, 1949 M. R. FIELDS 2,470,297

INHALATOR Filed sept. 4, 1947 IN VEN TOR.

@ci Qaida Patented May 17, 1949 INHALATOR Mack R. Fields, Libertyville,lll., assigner to Abbott Laboratories, North Chicago, lll., acorporation of Illinois Application September 4, 1947, Serial No.772,104

(Cl. 12S-266) 3 Claims. 1

My invention relates to therapeutic medication and includes among itsobjects and advantages increased convenience in medication with drymedicaments in powder form, especially with respect to accuracy ofdosage and accurate placement of the material.

Many useful medicaments, and especially penicillin and relatedantibiotics, are subject to substantial or, in some instances, completealteration by the stomach juices when administered orally. Differentpatients vary widely in the condition of the alimentary canal and theextent to which oral dosages will be impaired in effectiveness. In fact,the same patient will react differently to the same dosage at dilerenttimes, because the condition of the patients alimentary canal variesfrom time to time.

0n this account, precision in treatment has the general treatment thusresulting with high local concentration of the same medicament inwhatever body cavity is utilized, including the lungs, and the throat, Y

In addition to Water-soluble anti-biotics, solid inhalation therapy isof value in connection with certain vasoconstrictors, and is indicatedfor at least some of the known anti-histamine drugs. Illustrativeexamples of vaso-constrictors are: epinephrine hydrochloride, isopropylepinephrln and 2-aminoheptane.. Illustrative examples of anti-histamineagents are: N-(alpha-pyridyD- N (alpha-thenyl) N', Ndimethylethylenediamine hydrochloride, and N-(alpha-pyridyl) -N-(benzyl) -N',N-dimethylethylenediamine hydrochloride.

Data available so far do not support any reliable generalizations. Moreparticularly, the mere fact that a drug is ineffective or toxic whenadministered orally aiords no indication that it is suitable for solidinhalation therapy. Many such therapeutic agents which are watersoluble, will be found effective by solid inhalation, but both theeffect and the degree of effectiveness need to be establishd by spcictest in connection with each substance.

However, especially when the local application is in the lungs, a widevariability in the proportion of powdered material that comes to rest inthe nose and in the bronchial tubes and in o0 2 the actual lung itselfcan only be avoided by a substantial constancy in the method ofinhalation.

According to the invention, I succeed in obtaining such constancy byproviding apparatus which is to be utilized by the patient by breathingin and out in a simple, substantially normal way. I utilize the energyof the -patients breathing to deliver into each charge of air inhaled asmall substantially constant charge of powdered medicament, which chargeis delivered quickly, shortly after inhalation begins, and nds its wayto the depth of the cavity long before inhalation is finished. Thus theapparatus itself and the nose and bronchial tubesl are thoroughly sweptand scavenged with pure air during a major portion of thebreathing-in-process. I have found that administration in this way notonly contributes to deep penetration of the medicament, but that itbecomes unnecessary to pulverize or micronizev the medicament into atrue smoke. The use of larger particles tends to increase thereliability with which a uniform fraction of the material will passl onthrough the nose and bronchial tubes without getting caught on the moistWalls.

Whereas other methods of administration by inhalation known to me areobjectionable because the apparatus is expensive or complicated, orbecause the amount of medicament rendered effective for therapeuticpurposes varies uncontrollably over a range of several hundred per cent,or both, it is possible according to the invention to work outdependable procedures which do not require hospitalization or therepeated checking of blood samples.

In the accompanying drawing:

Figure l is a side elevation of an inhalator according to the invention:

Figure 2 is a plan view of the same inhalator :from above;

Figure 3 is a plan view of the same inhalator from below;

Figure 4 is a section as on line 4-4 of Figure 2;

Figure 5 is a longitudinal section of the capsule before it is assembledwith the inhalator; and

Figure 6 is a perspective` of the device in use.

In the embodiment of apparatus selected for illustration, the mainhousing IIJ is of transparent plastic,A molded in two halves cementedtogether on the plane of the section of Figure 4. The body deilnesachamberJZ having an outlet opening I4 for the discharge of air into themouth of the patient. Flanges I6 assist the patient in holding thedevice in place with the teeth as partially indicated in dotted lines inFigure 1. The top opening I8 closed by a. plug 20 when it happens thatmedication through the mouth only is desired. Normally, it will receivea lower end of a bifurcated nose connector piece 22. This is of flexiblematerial with its lower end ,fitted into the opening I8 and the two tips24 entered inthe nostrils of the patient. With a suitable grade ofrubber the bottom portion may advantageously have a wall thickness ofabout 68 thousandths of an inch, which will secure a satisfactory gripin the opening, and the wall may taper to about 30 thousandths of aninch at the end of the tip so that the tips 24 will be soft andcomfortable to the users nostrils.

Means are provided for discharging a predetermined amount of powderedmedicament small enough in quantity to be carried into the air-filledcavity receiving it during a first and preferably minor fraction of eachbreathing in, or inhalation. By making the energy requirement for thedischarge of the medicament extremely low, it is possible to make thisdischarge, and the timing of the discharge, completely automatic, and toenergize it by the energy supplied by the patient in inhaling withoutimposing enough burden on the muscular strength of the patient to causeany material labor or annoyance, I have illustrated a capsule 26inserted into place in a rubber grommet 28 set in the upper wall of thebody l0. The capsule, when in use, has anopen lower end obstructed by aiine screen 30. Suitable results have been obtained with screens fromabout 40 to 80 mesh. To jar, or agltate, the 4capsule with the rightforce at the right time, I provide an inlet tube 32 in which lies a ball34 freely movable from one end of the tube to the other but restrainedfrom falling out by a lug 36 and from falling into the chamber by a lug38. Upon reference to Figure 4, it will be observed that the parts areso proportioned that the ball 24 may strike the capsule 28 at the end ofits inward movement and thus deliver a blow to discharge powder throughthe screen 30.

The chamber I2 has another inlet 40 in its bottom controlled by thesimple flap check valve 42. It will be apparent that at the beginning ofeach inhalation the ap 42 closes immediately and the suction exerted bythe patient then throws the ball 34 quickly from the bottom of the tube32 up into ycontact with the capsule 28. simple steel ballfunctions verywell in this connection, but with a ball of aluminum the parts may bedesigned to secure a slightly better mechanical action,

The inner end of the tube 32 is provided with four slots 44 extendingdown the tube far enough so that the ball uncovers and opens them whenit moves to the upper end of its path. Thus,` the user does notexperience any material restriction on his breathing.

The capsule 26 1s filled and sealed at the place of manufacture. It mayadvantageously be shipped with its lower end covered with a rubber cap46, which, in undistorted condition, has its bottom dished upward asindicated at 48 in Figure so that pushing thecap home on the lower endof the capsule will stress the bottom 48 and cause it to remain gentlypressed upward against the screen 30 until the cap is removedpreparatory to using the capsule.

The upper portion of the capsule is shaped for convenient handling bythe user. I have illustrated a plastic capsule which may be formedinitially with a middle diaphragm 50 at the top of the capsule proper26, and substantially arcuate closed wall sections rising above thediaphragm 50 and of slightly larger diameter than that of the capsuleproper 26 to dene an abutment shoulder 52 to engage the grommet 26. The

4 segmental upper portions may then be heated slightly and gentlypressed over to dene an openended arch 54, the ends of which mayconveniently be engaged by the finger tips of the user when inserting orwithdrawing the capsule.

I prefer to curve the passage 32 in a generally arcuate path down and intoward the user to reduce the overall length of the device,

By Varying the neness of the powder and the mesh of the screen 30various powdered medicaments can be administered at various rates. Withsodium penicillin I prefer to use a screen of about 60 mesh and it isnot hard to granulate the powder by trial and error to a grain size suchthat an administration of 100,000 units is easily accomplishedby normalbreathing, in from three to six minutes. I have also found that smootherand more accurate mechanical action can be secured by mixing thepenicillin with at least a little other material intended to function asa diluent or vehicle. Specifically, 100,000 units of graular penicillinrepresents about 90 milligrams of material and the addition to thecharge of about 25 milligrams of sulfanilamide makes up into a combinedpowder that secures materially better and more accurate mechanicalfunctioning. A patient inhaling such a charge will receive a full normaldose of penicillin but only about 10% of a normal dose of sulfanilamide.It will be obvious that the charge may include various combinations ofmedicaments with or without completely inert vehicles.

Because the energy of the users breath actuates the timed discharge,there is no other instrumentality with which any synchronism needs to bemaintained. Further, because there is no extraneous power imposed on theingoing air stream, the patients natural and normal lung movements arenot disturbed and upset yby being pushed or pulled in a way that isalways uncomfortable and frequently unexpected and bad l for the moraleof the patient.

Others may readily adapt the invention for use under various conditionsof service by empolying one or more of the novel features involved, orequivalents thereof. As at present advised with respect to the apparentscope of my invention, I desire to claim the following subject mattei'.

I claim:

1. Equipment for introducing an air-borne powdered medicament into bodycavities, which comprises: a rigid transparent plastic body dening achamber; said chamber being formed with one end outlet shaped to begripped between the teeth of the user; said chamber having a lateraloutlet positioned below the users nostrils when said first outlet isgripped by the users teeth; a flexible branched conduit having a singlelower opening fitting said second chamber outlet, and double upperopenings of va size to t into the nostrils of the user; said upperopenings being deflnedby flexible material; a tubular inlet at the endof the chamber opposite said first outlet; a ball of diameter sufficientto substantially close said tubular inlet; said tubular inlet beinginclined so that the ball normally resides at the intake end of saidinlet; an obstruction at the intake end of said inlet end to preventegress of said ball; an obstruction at the discharge end of said tubularinlet to prevent discharge of said ball into said chamber; said tubularinlet having lateral vent opening adjacent its discharge end positionedto be uncovered by said ball; a removable container for medicament;

-socket means in the wall oi said chamber for receiving and holding saidcontainer in a position to. be struck by said ball at-the end of itsinward movement; said container having a foraminated bottom; and acharge of powdered medicament in said container of grain size smallenough to deliver an increment of medicament through said foraminatedbottom each time said ball strikes said container at the beginning ofinhalation; a return flow discharge opening in said chamber, and aquick-acting check valve permitting gas to issue from said chamberduring exhalation but closing at the beginning of inhalation to compelthe air inhaled to enter through said tubular inlet.

2. Equipment for introducing an air-borne medicament into body cavities,which'comprises: a rigid transparent plastic body dening a chamlber;said chamber being formed with one end outlet shaped to deliver uid tothe mouth of the user: said chamber having a lateral outlet positionedbelow the users nostrils when said rst outlet is gripped by the usersteeth; a conduit means for delivering gas from said second chamberoutlet into the nostrils of the user; a tubular inlet at the end of thechamber opposite said first outlet: a ball of diameter sufilcient tosubstantially close said tubular inlet; said tubular inlet beinginclined so that the ball normally resides at the intake end of saidinlet; an obstruction at the intake end of said inlet end to preventegress of said ball; an obstruction at the discharge end of said tubularinlet to prevent discharge of said ball into said chamber; said tubularinlet having lateral vent openings adjacent its discharge end positionedto be uncovered by said ball; a removable container for medicament;socket means in the wall of said chamber for receiving said container ina position to be. struck by said ball at the end of its inward movement:said container having a foraminated bottom; and a charge of powdered-medicament in said container of grain size small enough to deliver anincrement of medicament through said ioraminated bottom each time saidball strikes said container at the beginning of inhalation; a. returnflow discharge opening in said chamber: and a quick-acting check valvepermitting gas to issue from said chamber during exhalation but closingat the beginning of inhalation to compel .the air inhaled to enterthrough said tubular inlet.

3. Equipment for introducing' an airborne powdered medicament into bodycavities, which comprises: a body dening 'a chamber; said chamber beingformed with an outlet shaped to deliver iluid -to the person o! theuser; an inlet to said chamber; a medicament container in said chamberhaving a foraminated Wall; means actuated by the initial flow of inhaledgas through said inlet, for jolting said container to release anincrement of medicament through said i'oraminated wall; said chamberbeing provided with an additional outlet for the exit of gas duringexhalation; and an automatic check valve in said additional outlet toprevent inward flow.

MACK R. FIELDS.

REFERENCES CITED The following references are of record in the ille of`this patent:

UNITED STATES PATENTS

